US10112034B2ActiveUtilityA1

Adjustable-length drug delivery balloon

58
Assignee: J W MEDICAL SYSTEMS LTDPriority: Jun 29, 2007Filed: Jun 15, 2016Granted: Oct 30, 2018
Est. expiryJun 29, 2027(~1 yrs left)· nominal 20-yr term from priority
A61M 2025/1081A61M 2025/1068A61M 25/10A61M 2025/105A61F 2/958
58
PatentIndex Score
0
Cited by
32
References
41
Claims

Abstract

A drug or agent coated balloon having a length which is adjustable in vivo is described herein. The balloon is configured to be coated or coatable with one or more drugs where the coating may be applied prior to advancement into a patient body or prior to balloon expansion within the patient body. The length of the expandable portion of the balloon is adjustable to approximate a length of the tissue region to be treated. Moreover, the drug-coated balloon may be used alone or it may be utilized to deploy luminal prostheses having one or more linked or otherwise coupled segments.

Claims

exact text as granted — not AI-modified
What is claimed is: 
     
       1. A method of treating a region of a vessel wall, comprising:
 positioning a catheter having an inflatable balloon positioned thereon in proximity or adjacent to the region of vessel wall within a patient body; 
 adjusting a position of a sheath with respect to the balloon such that an exposed portion of the balloon is coextensive with the region of vessel wall while a second portion of the balloon is covered by the sheath; 
 depositing, in vivo, at least one agent upon a surface of the balloon within the sheath; and 
 expanding the exposed portion of the balloon such that the at least one agent disposed upon the exposed portion of the balloon contacts the region of vessel wall. 
 
     
     
       2. The method of  claim 1  wherein positioning a catheter comprises intravascularly advancing the catheter within the patient body. 
     
     
       3. The method of  claim 1  wherein adjusting a position comprises retracting the sheath with respect to the balloon such that a distal end of the sheath overlies the balloon proximal to the exposed portion of the balloon. 
     
     
       4. The method of  claim 1  wherein the sheath defines at least one lumen therethrough in fluid communication between at least one opening defined along an inner surface of the sheath and the surface of the balloon. 
     
     
       5. The method of  claim 4  wherein the at least one agent is delivered through the at least one lumen in the sheath. 
     
     
       6. The method of  claim 1  wherein depositing the at least one agent comprises delivering the at least one agent through a plurality of openings defined along an inner surface of the sheath upon the surface of the balloon. 
     
     
       7. The method of  claim 1  further comprising positioning at least one stent segment over the balloon such that the at least one stent segment overlies the exposed portion of the balloon. 
     
     
       8. The method of  claim 7  wherein the at least one stent segment is positioned over the balloon prior to expanding the exposed portion of the balloon. 
     
     
       9. The method of  claim 7  further comprising expanding the at least one stent segment upon the exposed portion of the balloon into contact against the region of vessel wall. 
     
     
       10. The method of  claim 7  wherein the at least one stent segment is expanded after the balloon is expanded without the at least one stent segment thereon. 
     
     
       11. The method of  claim 7  wherein the at least one stent segment is expanded before the balloon is expanded without the at least one stent segment thereon. 
     
     
       12. The method of  claim 7  wherein the stent carries a therapeutic agent. 
     
     
       13. The method of  claim 12  wherein the agent on the balloon is different than the agent on the stent. 
     
     
       14. The method of  claim 1  wherein the exposed portion of the balloon is contacted against the region of vessel wall for a sustained period of time of between 10 seconds to 10 minutes. 
     
     
       15. The method of  claim 1  wherein the exposed portion of the balloon is contacted against the region of vessel wall for a sustained period of time of between 30 to 150 seconds. 
     
     
       16. The method of  claim 1  wherein the exposed portion of the balloon is contacted against the region of vessel wall for a sustained period of time of 60 seconds. 
     
     
       17. The method of  claim 1  further comprising shunting blood through the balloon via a perfusion lumen while maintaining contact between the exposed portion of the balloon and the region of vessel wall. 
     
     
       18. The method of  claim 17  wherein shunting blood comprises flowing the blood through the perfusion lumen which extends from a first location proximal to the balloon to a second location distal to the balloon. 
     
     
       19. The method of  claim 1  further comprising irradiating the exposed portion of the balloon intravascularly and/or extracorporeally such that a concentration of nanoparticles contained within a carrier upon the balloon is heated. 
     
     
       20. The method of  claim 19  further comprising liquefying the carrier such that the agent is released into the vessel wall. 
     
     
       21. A method of treating a region of a vessel wall, comprising:
 positioning a catheter having an inflatable balloon positioned thereon in proximity or adjacent to the region of vessel wall; 
 adjusting a position of a sheath with respect to the balloon such that an exposed portion of the balloon is coextensive with the region of vessel wall while a second portion of the balloon is covered by the sheath; 
 depositing at least one agent upon a surface of the balloon within the sheath, wherein depositing the at least one agent comprises delivering the at least one agent through a plurality of openings defined along an inner surface of the sheath upon the surface of the balloon; and 
 expanding the exposed portion of the balloon such that at least one agent disposed upon the exposed portion of the balloon contacts the region of vessel wall. 
 
     
     
       22. The method of  claim 21  further comprising depositing at least an additional agent upon the balloon within the sheath. 
     
     
       23. The method of  claim 22  wherein the first agent is a restenosis inhibitor and the additional agent is selected from an anti-platelet agent, a thrombus inhibitor, an endothelial cell promoter, or endothelial cell attractor. 
     
     
       24. The method of  claim 22  further comprising re-adjusting the position of the sheath with respect to the balloon such that the exposed portion of the balloon is coextensive with the region of vessel wall. 
     
     
       25. The method of  claim 24  further comprising re-expanding the exposed portion of the balloon such that the additional agent disposed upon the exposed portion of the balloon contacts the vessel wall. 
     
     
       26. The method of  claim 21  further comprising repositioning the catheter in proximity or adjacent to a second region of vessel wall. 
     
     
       27. The method of  claim 26  wherein repositioning comprises retracting the sheath with respect to the balloon such that a distal end of the sheath overlies the balloon proximal to the exposed portion of the balloon. 
     
     
       28. The method of  claim 27  further comprising positioning at least one stent segment over the balloon such that the at least one stent segment overlies the exposed portion of the balloon. 
     
     
       29. The method of  claim 28  wherein the at least one stent segment is positioned over the balloon prior to expanding the exposed portion of the balloon. 
     
     
       30. The method of  claim 28  further comprising expanding the at least one stent segment upon the exposed portion of the balloon into contact against the second region of vessel wall. 
     
     
       31. The method of  claim 21  further comprising deflating the exposed portion of the balloon and re-covering the balloon with the sheath. 
     
     
       32. The method of  claim 21  wherein the at least one agent is delivered through a lumen in the sheath. 
     
     
       33. The method of  claim 21  further comprising depositing at least an additional agent upon the balloon within the sheath. 
     
     
       34. A method of treating a stenosed region of vessel wall previously treated, comprising:
 positioning a catheter having an inflatable balloon positioned thereon in proximity or adjacent to the stenosed region of vessel wall; 
 adjusting a position of a sheath with respect to the balloon such that an exposed portion of the balloon is coextensive with the stenosed region of vessel wall while a second portion of the balloon remains covered by the sheath; 
 expanding the exposed portion of the balloon such that at least one agent disposed upon the exposed portion of the balloon contacts the stenosed region of vessel wall; and 
 infusing the at least one agent upon a surface of the balloon while adjusting the position of the sheath. 
 
     
     
       35. The method of  claim 34  wherein positioning a catheter comprises intravascularly advancing the catheter within a patient body. 
     
     
       36. The method of  claim 34  wherein adjusting a position comprises retracting the sheath with respect to the balloon such that a distal end of the sheath overlies the balloon proximal to the exposed portion of the balloon. 
     
     
       37. The method of  claim 34  wherein the at least one agent is delivered through a lumen in the sheath. 
     
     
       38. The method of  claim 34  wherein infusing the at least one agent comprises passing the at least one agent through a plurality of openings defined along an inner surface of the sheath upon the surface of the balloon. 
     
     
       39. The method of  claim 34  wherein expanding the exposed portion comprises contacting a previously deployed stent disposed along the stenosed region. 
     
     
       40. The method of  claim 34  further comprising shunting blood through the balloon via a perfusion lumen while maintaining contact between the exposed portion of the balloon against the region of vessel wall. 
     
     
       41. The method of  claim 40  wherein shunting blood comprises flowing the blood through the perfusion lumen which extends from a first location proximal to the balloon to a second location distal to the balloon.

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